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Last Updated: June 28, 2022

VISTOGARD Drug Patent Profile


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When do Vistogard patents expire, and what generic alternatives are available?

Vistogard is a drug marketed by Wellstat Therap and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.

DrugPatentWatch® Generic Entry Outlook for Vistogard

Vistogard was eligible for patent challenges on September 4, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 10, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VISTOGARD
International Patents:175
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 67
Patent Applications: 267
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in VISTOGARD?VISTOGARD excipients list
DailyMed Link:VISTOGARD at DailyMed
Drug patent expirations by year for VISTOGARD
DrugPatentWatch® Estimated Generic Entry Opportunity Date for VISTOGARD
Generic Entry Date for VISTOGARD*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for VISTOGARD

US Patents and Regulatory Information for VISTOGARD

VISTOGARD is protected by two US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VISTOGARD is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VISTOGARD

Acylated uridine and cytidine and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: EMERGENCY TREATMENT OF ADULT & PEDIATRIC PATIENTS FOLLOWING FLUOROURACIL OR CAPECITABINE OVERDOSE,OR WHO EXHIBIT EARLY-ONSET,SEVERE OR LIFE-THREATENING CARDIAC OR CNS TOXICITY OR UNUSUALLY SEVERE ADVERSE REACTIONS WITHIN 96 HOURS

FDA Regulatory Exclusivity protecting VISTOGARD

EMERGENCY TX OF PTS FOLLOWING A FU OR CAPECITABINE OD, OR WHO EXHIBIT EARLY-ONSET, SEVERE OR LIFE-THREATENING TOXICITY AFFECTING THE CARDIAC SYSTEM OR CNS, AND/OR EARLY-ONSET, UNUSUALLY SEVERE AR W/IN 96 HRS FOLLOWING THE END OF FU OR CAPECITABINE ADMIN.
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for VISTOGARD

See the table below for patents covering VISTOGARD around the world.

Country Patent Number Title Estimated Expiration
Australia 667676 See Plans and Pricing
Canada 2504078 NUCLEOSIDES PYRIMIDINE ACYLES UTILISES POUR TRAITER LA TOXICITE DES AGENTS CHIMIOTHERAPEUTIQUES ET ANTIVIRAUX (TREATMENT OF CHEMOTHERAPEUTIC AGENT AND ANTIVIRAL AGENT TOXICITY WITH ACYLATED PYRIMIDINE NUCLEOSIDES) See Plans and Pricing
Denmark 176007 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VISTOGARD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 SPC/GB17/049 United Kingdom See Plans and Pricing PRODUCT NAME: TRIFLURIDINE WITH TIPACRIL HYDROCHLORIDE; REGISTERED: UK EU/1/16/1096/001(NI) 20160427; UK EU/1/16/1096/002(NI) 20160427; UK EU/1/16/1096/003(NI) 20160427; UK EU/1/16/1096/004(NI) 20160427; UK EU/1/16/1096/005(NI) 20160427; UK EU/1/16/1096/006(NI) 20160427; UK PLGB 05815/0112 20160427; UK PLGB 05815/0113 20160427
1849470 2017C/028 Belgium See Plans and Pricing PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470 LUC00036 Luxembourg See Plans and Pricing PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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